MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE RIGHT 11MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994)

Event Date 07/15/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a knee arthroplasty revision approximately three (3) weeks post-operatively to address knee pain after a fall.During the revision, the articular surface was identified to be significantly worn.Attempts have been made; however, no additional information is available.

Manufacturer Narrative

(b)(4).D10 - concomitant devices - unknown persona tibial tray catalog #: ni lot #: ni, unknown persona femoral component catalog #: ni lot #: ni, unknown stryker bone cement catalog #: ni lot # ni g2 - report source - foreign: canada the complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : investigation incomplete.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being filed to relay additional information.D10 - concomitant devices - persona posterior stabilized cemented femoral component standard right size 9 catalog #: 42500606602 lot #: 65711708, persona stemmed cemented tibial component right size f catalog #: 42532007502 lot #: 65851078, unknown stryker bone cement catalog #: ni lot #: ni.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual evaluation of pictures provided confirmed that the articular surface was worn.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE RIGHT 11MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18038104
• MDR Text Key: 326950897
• Report Number: 3007963827-2023-00290
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42522400711
• Device Lot Number: 65895489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose